The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis

What Was Tested

This registered phase 3 trial tested ACTH (Corticotropin) for rheumatoid arthritis.

Patients will be assigned to receive either Depo Medrol or Acthar treatment.

A synovial biopsy, blood draws, synovial fluid aspiration, and physician assessments will be performed before and after initiating treatment.

It had two arms (groups): Acthar (experimental) and Depo Medrol (active comparator).

The registry classes the interventions as drug.

More on the Plan

At screening visit, inclusion and exclusion criteria will be assessed.

If assessments have not been completed to verify these criteria, they will be performed at this visit.

After patients are confirmed to meet criteria, patient disease activity will be assessed and blood draw, synovial aspiration, and biopsy will be performed before first treatment injection.

About 5 days after this first treatment injection, these assessment and samples will be performed again.

Who Took Part

6 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Anti-Cyclic Citrullinated Peptide positive rheumatoid arthritis. On a stable regimen of medications. Moderate to severe disease activity as measured by the Clinical Disease activity index (CDAI), or DAS28 (Disease Activity Score) within 30 days of starting the study. Patients must have at least one joint with the following features within 30 days of starting the study:. Joint must be tender.

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: patients on anti-coagulation therapy; patients with an active infection; patients with any history of joint infection.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got ACTH (Corticotropin) and who got the comparison, which limits bias.

Groups ran in parallel: each of the rheumatoid arthritis participants stayed in one arm throughout.

Only one side, usually the rheumatoid arthritis participants, was kept unaware of whether ACTH (Corticotropin) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2018-10-02 with completion listed for 2020-02-26.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment (time frame: Samples collected about 30 minutes before first treatment injection and about five days after this first injection). Initial degree of inflammation, as measured by a pathologist during histological assessment (time frame: Samples collected about five days after first injection of treatment).

It also tracked 12 secondary outcomes, for example Initial disease activity as measured by blinded clinician using DAS28 (Disease Activity Score), Disease activity after short-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score), Disease activity after long-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score), Initial number of tender and swollen joints as measured by clinician while palpating 28 specified joints, Number of tender and swollen joints after short-term treatment as measured by clinician while palpating 28 specified joints and Number of tender and swollen joints after long-term treatment as measured by clinician while palpating 28 specified joints.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of ACTH (Corticotropin) in 6 people with rheumatoid arthritis.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, Rheumatoid arthritis research.